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Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis.

NCT07758270 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2026-08-11

No results posted yet for this study

Summary

REDEFINE-MS is a research study for people with relapsing multiple sclerosis (MS) who are participating in the RESHAPE-MS trial. The study aims to better understand how remibrutinib affects inflammation in the brain and spinal cord by using PET imaging, MRI scans, blood samples, and cerebrospinal fluid (CSF) samples collected before treatment and again six months later. \[REDEFINE\_p...2026\_clean \| Word\] The main question the study is trying to answer is whether remibrutinib changes immune activity and inflammation in people with MS, and whether these changes can be measured using imaging and biological markers that may help predict future disease progression and treatment response.

Conditions

  • Multiple Sclerosis (MS) - Relapsing-remitting

Interventions

DRUG

Remibrutinib

Participants with relapsing multiple sclerosis enrolled in the parent RESHAPE-MS study who are randomized to receive remibrutinib. Participants undergo PET imaging, MRI, blood collection, and cerebrospinal fluid collection as part of REDEFINE-MS.

DRUG

Ocrelizumab (US)

Participants with relapsing multiple sclerosis enrolled in the parent RESHAPE-MS study who are randomized to continue ocrelizumab. Participants undergo PET imaging, MRI, blood collection, and cerebrospinal fluid collection as part of REDEFINE-MS.

Sponsors & Collaborators

Principal Investigators

  • Matthew R Brier, MD, PhD · Washington University School of Medicine

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2029-08-15
Completion
2030-08-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758270 on ClinicalTrials.gov